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Abaloparatide linked with reduced risk of fractures in women with osteoporosis
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Compared with placebo, use of subcutaneous abaloparatide reduced the risk of new vertebral and nonvertebral fractures among postmenopausal women with osteoporosis during a period of 18 months, according to results.
Researchers randomly assigned 2,463 postmenopausal women with osteoporosis to receive either abaloparatide, teriparatide or placebo for 18 months. According to researchers, the percentage of participants with new vertebral fractures in the abaloparatide vs. placebo group was the primary end point. Researchers also looked at change in bone mineral density in the total hip, femoral neck and lumbar spine for the abaloparatide vs. placebo group and time to first incidence of nonvertebral fracture as secondary end points.
Overall, 77.2% of patients completed all study visits, with 73.5% of patients in the abaloparatide group; 80.4% of patients in the teriparatide group; and 77.6% of patients in the placebo group. Researchers found more patients in the placebo group had new morphometric vertebral fractures compared with the abaloparatide and teriparatide groups.
According to results, participants in the abaloparatide group had greater increases in bone mineral density for the femoral neck and total hip at 6 months compared with the teriparatide group. From baseline to 18 months, the abaloparatide group also had significant changes in bone mineral density at the total hip, femoral neck and lumbar spine vs. the placebo group.
Kaplan-Meier showed an event rate for nonvertebral fractures of 2.7% in the abaloparatide group vs. 4.7% in the placebo group and 3.3% in the teriparatide group. Researchers predefined hypercalcemia as albumin-corrected serum calcium level of at least 10.7 mg/dL. The overall incidence of this condition was significantly lower in the abaloparatide group (3.4%) vs. the teriparatide group (6.4%). – by Casey Tingle
Disclosures: Miller reports he is a member of scientific advisory boards for AgNovos, Amgen, Eli Lilly, Merck, Radius Health, Roche and Ultragenyx; receives research grants from Alexion, Amgen, Boehringer-Ingelheim, Daiichi-Sankyo, Eli Lilly, Immunodiagnostics, Merck, Merck Serono, National Bone Health Alliance, Novartis, Radius Health, Regeneration, Roche Diagnostics and Ultragenyx; and serves on data and safety committees for Allergan and the Grünenthal Group. Please see the full study for a list of all other authors’ relevant financial disclosures.
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